Wearable device

ABSTRACT

A wearable device comprising a memory storing a database of product codes and associated product recommendations derived from personalised biological information, a product code reader for reading a product code or data from a product, and a processor for using a read product code or read data to perform a look-up in the database to obtain a product recommendation for the associated product. The wearable device further comprises an indicator for providing an indication of the obtained product recommendation to a wearer of the device

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of International ApplicationNo. PCT/GB2016/053052, filed Sep. 30, 2016, which claims priority to GBApplication No. GB1517393.3, filed Oct. 1, 2015; Chinese Application No.CN201620146860.0, filed Feb. 26, 2016; U.S. application Ser. No.15/152,921, filed May 12, 2016; and GB Application No. GB1613229.2,filed Aug. 1, 2016, the entire contents of each of which being fullyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a method, apparatus and system forsecurely transferring to consumers' biological information, such asgenetic and/or microbiome information, and/or further informationrelated to biological information, between computer systems and devices.Such information may be used for the purpose of purchasing a product orservice of choice. The present invention also relates to a method andapparatus for providing product recommendations. An example of such anapparatus may be a wearable device for providing productrecommendations.

BACKGROUND OF THE INVENTION

Advancements in sequencing and healthcare technologies and breakthroughsin science have revolutionised the field of genetics and microbiome dataanalysis and interpretation, making such services cost-effective andaccessible to the general public. Every day new genetic traits are beingdescribed, generating a continuously expanding catalogue of biomarkersthat affect the health, wellbeing, and, in the case of geneticvariations phenotype, of living organisms, including humans, animals,microbes, fungi, and plants.

Identifying individual differences at a molecular and cellular level hasallowed for a deeper layer of personalisation in medicine, such as fordrug dosage and treatment selection, as well as in lifestyle improvementand management, by tailoring personal care products ranging fromcosmetics and nutraceuticals, to services that enhance fitness,weight-loss regimes etc. A number of private companies and clinics havebeen created in order to cater for the growing consumer genetics orhealthcare markets. Nevertheless, limitations in the technologiesutilised restrict the commercialisation of such approaches to lab-basedservices, compromising delivery speed, business models and privacy.Depending on the samples they work on, this may require theuser/customer/patient to compromise on privacy and convenience.

Currently, an individual that wants to gain access to informationrelated to his/her genetics or health condition, whether for a specificpurpose/concern or for general interest, needs to go through a privateclinic or professional body, provide sample to central labs (either inperson or by post). Such a process is time consuming, inconvenient andmay invade the individual's privacy. For example, many tests are basedon blood analysis, which requires the individual to attend a samplecollection session with an expert. In the most convenient availableapproach, he/she needs to order a kit for collecting saliva sample andthen post it to the lab. The individual must avoid eating and drinkingfor certain time, and is responsible for handling the sample collectionprocess.

A conventional process for personalised medical testing is as follows:

1) Order online a sample collection kit from the service provider;2) Receive the kit and collect the biological sample (usually saliva)—atthis stage, the customer may also be asked to fill in a questionnairethat will be analysed together with the test results;3) Send the sample back to the service provider via post; the samplewill then be processed by skilled lab staff, e.g. using various geneticanalysis assays; and4) 4-8 weeks later, the customer will be sent electronically or via posta generic analysis report, e.g. listing his/her different variations inthe DNA. In some cases, the service provider may make a productrecommendation or offer a bespoke product designed or selected accordingto the client's test results.

These conventional approaches require the costumer to send his/herbiological sample to some remote location, usually via post, in order tobe processed and analysed. This introduces confidentiality concerns withregards to:

1) who analyses the biological sample and how and where this is done;2) how and where the genetic or health information is stored, or safelydiscarded;3) how is the customer's personal information linked to his/her geneticor health profile;5) who can have access to the customer's health information (especiallywhen the information is as personal as genetic information);6) in many cases, prior to releasing the analysis report, the customeris asked to fill in questionnaires in relation to his/her medicalhistory, lifestyle habits etc—sharing such information adds anotherlevel of concern.

At this point it should be highlighted that confidentiality concerns arenot solely related to the genetic results, i.e. what genetic variantsthe customer carries, but also relate to the personal concerns thatmotivated the customer to consider having a genetic test, for instancepredisposition to impotence, baldness, drug addiction, alcoholism etc.If this information were to become available to health insuranceproviders, potential employers etc, an individual could be “geneticallystigmatised” and “classified”. The impact on an individual life could beenormous.

The majority of the currently available genetic services offer widegenome screening; e.g., using a predefined platform tagged with morethan 100,000 biomarkers and screening irrespectively all client samplesfor all genetic biomarkers. This means that a high proportion ofcustomers are being screened by default for genetic traits that they maynot want to know about; for instance, an individual purchasing a test inorder to determine his/her predisposition to detoxification will be alsoscreened for serious neurodegenerative diseases such as Alzheimer's andParkinson's disease. Access to information related to concerns that thecustomer did not initially have, may have a detrimental effect on theindividual's socio/psychological balance.

On the other hand, the majority of such services and tests focus on theindividuals themselves, whereas the reality is that we are not the onlyliving thing influencing our lives. We are living with hundreds ofthousands of bacteria in our body, good and bad. In order to provide aneffective personalized solution, we need to take these bacteria intoaccount. Companies like uBiome (http://ubiome.com/) have startedproviding direct-to-consumer services to analyse the gut microbiome. Butsimilarly, they require the customer to undergo a process as:

1—Order a kit online;

2—Collect own fecal matter;

3—Post the sample back to lab;

4—Wait for several weeks.

Besides the long turnaround time, some people might avoid this processbecause they are uncomfortable providing the type of sample required.Therefore, this process is not a fully compliant model.

A further disadvantage of many of the services available today is thatmuch of the information provided remains greatly un-interpretable and,consequently, of no interest or relevance to his/her day-to-day life.Whilst some services do offer to the customer personalised services orproducts, these may compromise the customer's freedom of choice andselection, and they do not take into account an individual's personalityand idiosyncrasy, including lifestyle choices, as well as religious,political, and cultural beliefs. For instance, a diet plan high in redmeat intake may be recommended for a person who is genetically prone tonot absorbing iron, even if the person is vegetarian or simply dislikesred meat. Another example might be a service that provides a tailoredpersonal care product, based on a customer's genetic traits, which hasbeen tested on animals. Such a product, even if specifically designed tothe individual's genetic profile, may conflict with his/her views onanimal welfare.

Finally, it will be appreciated that in a fast moving world where timeis a very important choice-making criterion, the speed with whichresults are provided is key. The fact that, currently, a biologicalsample has to be sent off remotely to a laboratory to be processed,means the costumer can be waiting weeks or even months for the results.The longer the time gap between ordering a genetic test and receivingthe results/recommended product, the more likely it will be that thecustomer fails to follow-up with associated purchases.

Taking into consideration the above, it becomes apparent that servicesthat require the sending of biological samples to be processed remotelyare often not very attractive from a consumer and/or a businesspoint-of-view. Furthermore, currently results are generallyproblem-based rather than solution-based. This highlights the desire forservices offering testing that a) can be performed by the consumer inhis/her own private environment, b) are based on targeted personal (e.g.genetics and microbiome) traits due to the customer's specific concerns,c) provide immediate, actionable results, and d) are delivered quickly,reliably, and securely.

Breath comprises about 3,000 compounds. Recent discoveries haveindicated the potential of breath analysis for understanding cellularactivities in the body. It is a non-invasive and highly compliant testto do.

The compounds in the breath are from the exhaust and waste of thecellular activates. They shed into blood and get exhaled from the lungs.Each blood circulation takes about 1 minute. Therefore, analysing breathcan indirectly help in analysing the whole body, either during thatminute, or over a longer period if the samples are accumulated. This hasmade breath analysis an attractive method to evaluate body condition. Ithas been used for many medical and non-medical applications, such as:

-   -   Alcohol level in blood    -   Early detection of cancer    -   Infectious disease    -   Asthma stratification    -   Bowel preparation    -   Irritable bowel syndrome    -   Lactose maldigestion and intolerance    -   Analysis of microbiome, e.g. Helicobacter pylori    -   Chylomicron remnant metabolism    -   Etc

For each of these tests, certain bio-markers are analysed. For example,different levels of certain volatile organic compounds may indicateearly stages of developing different cancers like lung, colorectal,breast, prostate, etc. They are increased because of the differentfunction of the tumour cells. Or the test might be on CH₄ and H₂ toanalyse lactose mal-digestion and intolerance.

There have been different technologies developed to enable such tests,from mass spectrometry in labs to handheld breathalysers for alcoholtests, with different complexities and accuracies. For example, FieldAsymmetric Ion Mobility Spectrometry (FAIMS) developed by OwlstoneMedical is a miniaturised semiconductor sensor that allowshigh-precision separation and measurement of breath compounds. OwlstoneMedical has portable devices on breath analysis and breath samplecollection. Such a platform potentially may allow integration of thesensors in mobile devices.

SUMMARY OF THE INVENTION

Whilst it is known that analysis of a biological sample can be used todetermine, for example, the benefits and risks associated with productsand activities, there are currently no commercial services thatintegrate home testing with product and service recommendations whilstat the same time ensuring security of biological information. What isproposed here is a service that integrates the home test, via theInternet, with a back-end results analysis service resulting in theprovision to users of product and service recommendations. The servicedoes not disclose biological information, such as genetic or microbiomeinformation, outside of the back-end provider, rather making use ofbiological filter codes. Such filter codes can be used for secureproduct mapping without disclosing genetic information or microbiomeinformation.

According to a first aspect of the present invention there is provided amethod of providing a user with analysis of test results for abiological sample. A test kit suitable for performing a test on saidbiological sample is selected or provided, the test kit comprising oneor more biomarkers for one or more areas of interest to the user. Thetest kit is provided to the user. The biological sample is then appliedto the test kit in order to generate test results dependent upon saidbiological marker(s), and the test kit coupled to a computer device ofthe user, either before, during or after applying the biological sampleto the test kit, and sending the test results from the computer device,via the Internet or another suitable network, to said remote, secureserver site. At the secure server site, the test results are processedto generate an analysis of the data and the analysis sent from theserver site to the user's computer device, or to another device, via theInternet or the other suitable network.

The biological sample may be derived from the microbiome of the user.

The test kit may consist of a unit that the person can breathe into. Theunit is connected to a sensing device that allows identifying andmeasuring the level of volatile organic compounds. The results from themeasurement may be patterns of signals. An example of such unit may bethe breathing mask and gas sensor developed by Owlstone Medical. Thebreathing mask (ReCIVA) allows collection of the breath sample and theFAIMS sensor allows measuring the level of the compounds in the breath.

The computer device may be any suitable device, such as a laptop, pc, orsmartphone. The computer device may be a wearable device.

The area of interest may be one of a lifestyle area, a product orservice or plural products or services, product ingredients, or acategory of products or services.

The method may comprise obtaining the biological sample from a sampleextracted locally from or by the user, or from a container storing asample extracted remotely. The test kit may comprise a test modulehaving a multiplicity of addressable test sites each of which is capableof independently carrying out a test for a biomarker that may be locatedat the test site, the or each said identified biomarker being providedat a test site. The method further comprises sending, together with saidtest results, an address of the test site(s) at which the identifiedbiomarker(s) is(are) provided, the method comprising, at the secureserver site, identifying a biomarker using the associated test siteaddress. The method is such that the biomarker is not identifiable fromthe sent data alone.

The analysis may comprises one or more biological filter codes/patterns.These codes/patterns may, for example, define characteristics of anindividual that result from the individual's genetic or microbiomemakeup, but without identifying that genetic or microbiome makeupitself.

The method may comprise installing a browser plug-in to a web browser onsaid computer device, the browser plug-in causing the browser tofacilitate filtering of product and/or service information displayed ina browser window on the basis of said analysis.

The method may comprise making all or a part of the analysis availableto an application installed on the computer device to facilitatefiltering of product and/or service information, or the provision ofadvice, by the application. The application may be configured to obtainproduct and/or service information read from a product or service labelby the computer device.

The analysis may comprise an identification of a product or service or arange of products or services. The analysis may also comprise web linksfacilitating online purchase of the products or services.

The step of identifying one or more biomarkers relevant to the or eacharea of interest comprises performing a lookup in a database of orcoupled to said remote secure server site, mapping areas of interest tobiomarkers.

The data identifying the biomarker(s) may not be provided to, or storedat, the user device or other device.

The method may comprise providing to the user device or other device auser public-private key pair, whilst providing to the remote secureserver site the user public key, the method comprising encrypting said(coded) analysis at the remote secure server site with the user publickey and decrypting it upon receipt at the user device or other deviceusing the user private key.

The or each biomarker may be a primer suitable for use in DNA synthesis.

The or each biomarker may be a volatile organic compound level in thebreath.

The test kit may comprise a breathing unit and a gas sensor unit withnecessary circuitry and processing modules.

The test kit may comprise an array of Ion Sensitive Field EffectTransistors, optical sensors, nanopores, nanowires and any other form ofmicroarray.

The method may also comprise receiving from the user computer, via a webportal, an identification of one or more areas of interest to the userand, at the remote secure server site, identifying one or morebiomarkers relevant to the or each area of interest.

According to a second aspect of the present invention there is provideda method of providing product advice to an individual, the methodcomprising reading data on product label using a computer device,interpreting the data using coded biological data stored on the device,the biological data relating to the individual and having beenpreviously obtained by means of an analysis of a biological sample (e.g.breath) obtained from the client, and based on the interpretation,presenting on a display of the device advice relating to the product,the advice being tailored to the individual. Said advice may relate tothe suitability of the product to the individual, and may recommend afurther analysis of a biological sample, that further analysis beingrelevant to the product.

Said data may be contained within a computer readable code of theproduct label, such as a QR code or a barcode.

According to a third aspect of the present invention there is provided awearable device comprising a memory storing a database of product codesand associated product recommendations derived from personalisedbiological (e.g. genetic or microbiome) information, a product codereader for reading a product code from a product, and a processor forusing a read product code to perform a look-up in the database to obtaina product recommendation for the associated product. The device furthercomprises an indicator for providing an indication of the obtainedproduct recommendation to a wearer of the device.

The device may be configured as a wristband or as a module attachable toa wristband, although it may take other forms such as a key fob, ring,or necklace.

A wearable device according to this aspect of the invention addresses anumber of shortcomings with the prior art approaches. In particular itcan restrict the type and amount of personal genetic information that isheld or sent outside of the wearable device. This reduces or eliminatesthe risk of a user's genetic information leaking out to third parties.It also makes the service useable in environments where (wireless)network connections are unavailable or insecure. Furthermore, byproviding a service by means of a wearable device, it becomes possibleto integrate into the service measurements and data collected directionfrom the wearer. For example, it becomes possible to modify the locallyheld data, or adapt a result, in dependence up local collectedphysiological and/or biochemical and/or activity data. For example, onecan envisage a service which is able to provide a product recommendationbased upon a user's personal genetics, but modify that recommendationbased upon sensed data that the user has recently engaged in exercise.

The product code may be a barcode in which case the product code readeris a barcode reader. The barcode reader may comprise a photo-imagingdevice such as a camera. The barcode reader may use optical componentsshared with a physiological sensor of the device. The device may furthercomprise an optical projector for projecting a targeting light onto aproduct to aid alignment of the photo-imaging device with a barcode.

By way of example, the indicator may comprise one or more of a displayscreen, coloured lights, a vibration motor, and a sound generator.

The device may comprise one or more physiological and/or biometricsensors and/or biosensors for monitoring a wearer, and a processor fordynamically updating product recommendations in the database usingsensed data.

The processor may be configured to receive a user input to switch on oroff dynamic updating of the product recommendations.

The device may comprise a wireless transceiver for communicating with apeer wearable device to exchange information within respectivedatabases, and a processor for recalculating the product recommendationsusing a combination of the received data and the existing data. Thedevice may further comprise a proximity detector for initiating anexchange of data with a peer device when the devices are in closeproximity to one another.

The database may comprise product codes and associated productrecommendations derived from personalised microbiome information foreach of a plurality of individuals, further comprising an interface forreceiving a user selection of one of the individuals.

The database may include markers to identify products whoserecommendation is influenced by hereditary personalised biological (e.g.genetic or microbiome) information, the device comprising means forreceiving a user input to filter products based on said markers.

The device may comprise a user interface for receiving from a user anotification of a product purchase, and means for storing thatindication in the database. The user interface may be configured toreceive from a user a notification that a product should be removed fromthe database.

The device may comprise a processor for automatically identifying thewearer, e.g. using voice recognition, biometric data, physiological dataetc.

The personalised biological information may comprise personalisedgenetic and epigenetic information.

The device may be configured to operate in a low power sleep mode and arelatively high power active mode, the device being operable in thesleep mode to recognise a generic product code and cause a switch to theactive mode.

The device may comprise a geographic location system for detecting thelocation of the device, a processor being configured to make accessibleor inaccessible related parts of the database in dependence upon thedetected location.

According to a fourth aspect of the present invention there is provideda system comprising a wearable device according to the above thirdaspect of the present invention and a computer device for communicatingwirelessly with the wearable device in order to populate and/or updatesaid database. The computer device may be a smartphone.

The computer device may comprise a memory storing said personalisedgenetic information and may be provided with an application for managingthe wearable device. Data to populate or update the database may beretrieved by the computer device from a cloud network.

According to a fifth aspect of the present invention there is provided amethod of conducting an online purchase of a product or service. Themethod comprises, at a user computer device, storing one or morebiological (e.g. genetic) filter codes, the biological filter codesmapping to respective products or services or categories of products orservices but not explicitly identifying a user's genetic or biologicalinformation. A web browser or application installed on the user computerdevice is used to retrieve available product or service data from a webportal. The filter code(s) are used to identify available products orservices that are suited to the user's genotype or microbiome. Thesuited products or services are identified to the user via a display orother user interface of the user's computer device.

According to a sixth aspect of the present invention there is provided asystem for providing a user with analysis of test results for abiological sample, comprising:

-   -   a) a computing device;    -   b) a communication network to which the computing device is        connected;    -   c) a secure server remote to and connected with the computing        device via the communication network;    -   d) a test kit connected to the computing device; the test kit        further comprising one or more biomarkers identified by the        secure server based on an identification of one or more areas of        interest to a user from the computing device;

wherein, the test kit is capable of receiving a biological sample andgenerating test results based thereon; the secure server capable ofgenerating an analysis based on the test results transmitted from thecomputing device to the secure server via the communication network.

According to a further aspect of the present invention there is provideda wearable device comprising a memory storing a database of productcodes and associated product recommendations derived from personalisedbiological information, a product code reader for reading a product codeor data from a product, and a processor for using a read product code orread data to perform a look-up in the database to obtain a productrecommendation for the associated product. The wearable device furthercomprises an indicator for providing an indication of the obtainedproduct recommendation to a wearer of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates schematically a service for allowing a customer toperform a test on genetic material or microbiome, and for providing thecustomer with an analysis of the results and product/servicerecommendations;

FIG. 2 is a flow diagram further illustrating the service of FIG. 1;

FIG. 3 illustrates schematically a web browser window including a newservice button provided by a browser plug-in;

FIG. 4 is a flow diagram illustrating the use of the new browser buttonto assist purchasing decisions;

FIG. 5 illustrates a procedure for providing a customer withproduct/service recommendations and utilising a dedicated app;

FIG. 6 illustrates schematically a DNA test module including an array oftests sites;

FIG. 7 illustrates schematically a semi-disposable DNA test kit;

FIG. 8 illustrates two approaches to providing personalisedgenetic-related advice to customers;

FIG. 9 illustrates schematically an end-to-end product ordering service;

FIG. 10 illustrates functionality for providing product recommendations;

FIG. 11 further illustrates the functionality of FIG. 10;

FIG. 12 further illustrates the functionality of FIG. 10;

FIG. 13 illustrates the use of the cloud to inform productrecommendations;

FIG. 14 illustrates schematically components of a wearable device;

FIGS. 15 and 16 illustrate a product recommendation scheme;

FIG. 17 shows a scheme for deriving product recommendations utilisingvarious information types;

FIG. 18 illustrates schematically components of a further wearabledevice;

FIG. 19 shows a further scheme for deriving product recommendationsutilising various information types;

FIGS. 20 and 21 illustrate alternative schemes for providing productrecommendations for a pair of individuals;

FIG. 22 further illustrates a scheme for merging user data;

FIG. 23 illustrates two wearable devices configured to share data;

FIG. 24 illustrates schematically a number of wearable deviceembodiments;

FIG. 25 illustrates various components of a wearable device;

FIG. 26 illustrates a wearable device and a computer device having amanagement app for managing the wearable device;

FIGS. 27 to 29 illustrate functions of a management app for managing awearable device; and

FIG. 30 is a flow diagram illustrating a system for productrecommendation based on breath testing.

DETAILED DESCRIPTION

Semiconductor nanotechnology and optical technologies have madesignificant contributions to people's lifestyle, especially byfacilitating hardware miniaturisation. Its application to the sequencingand genotyping industry has enabled so-called “lab-on-chip” systems.Depending on the biological questions/genes of interest,primer(s)/probe(s)—more generally referred to as “biomarkers”—aredesigned accordingly. A biomarker is an oligonucleotide such as a DNAmolecule and may target certain gene(s)/variation(s). A biomarker mayalternatively, for example, be an antibody or an antigen. Byapplying/choosing different types of biomarkers on such systems, acustomer can test his/her biological sample, DNA, RNA, protein etc,(extracted locally or remotely by a third party from e.g. saliva, blood,urine, tissue, stool, hair etc) for specific traits, as dictated bycertain lifestyle concerns or interest.

A service and technology will now be described which will open a new erain consumer genetic services; it offers speedy, direct-to-consumer,targeted genetic testing with actionable results, while at the same timeensuring maximum levels of privacy and confidentiality. The customer canhave complete control over the type of the genetic test (i.e.biomarkers), his/her biological sample, ownership and full access to thegenetic results, and, ultimately, freedom to choose from agenetically-suitable range of products and services that that bestmatches his/her own personality, preferences, and lifestyle. Whilst thefollowing examples relate to analysing the genotype of a humanindividual, there is no reason why the service cannot be extended toencompass other living organisms including animals, plants, microbes,fungus, etc.

FIG. 1 presents an overview of the service which is first accessed by acustomer via a web portal, referred to here as “THE PRIMER SHOP™”.Although not discussed here in any detail, THE PRIMER SHOP operates anumber of servers connected to the Internet and which host the serviceoffered by THE PRIMER SHOP. Via the web portal, THE PRIMER SHOP offers acatalogue of biomarkers, more specifically primers, with each primer/setof primers being associated with a lifestyle concern/question, e.g.;

-   -   “how does my body metabolise caffeine?”,    -   “what is the best vitamin supplement for me?”,    -   “what is the best treatment to help me quit smoking?”,    -   “how fast does my body recover from injury?” etc.

Although not exclusively the case, exemplary primers may be a strand ofshort nucleic acid sequences that serves as a starting point for DNAsynthesis. As is known in the prior art, such primers can be used in thedetection of genetic single-nucleotide polymorphisms (SNPs) and moreparticularly to determine the variation type (or allele) of a testedindividual for a given SNP. The primer(s) or multiplex array of primerscould be immobilised on the cartridge.

The available primers may be clustered based on the specific field ofapplication, e.g. weight-loss, fitness, nutrition etc. For example, acustomer looking for a personalised workout can choose from a list ofprimers used to analyse genes affecting fitness and diet. The number ofprimers suggested by THE PRIMER SHOP depends on the complexity of thequestion. However, the actual number of primers selected for the test iscustomer-dependant; in general, the more primers used in the assay, themore refined the analysis will be. THE PRIMER SHOP may offer primerbundles to the customer, especially where the chosen primers are sharedwithin different applications (e.g. primer A can be used to adviseregarding fitness and nutrition). Each primer configuration may bepurchased online or within a retail store.

Alternatively, a customer may seek to use THE PRIMER SHOP services dueto concerns/questions about a specific product (or category ofproducts), and the impact the product (or category of products) may haveon the individual based on his/her genetic background. In this case, THEPRIMER SHOP may suggest to the individual a customisable platform withone or more biomarkers, in order to evaluate the suitability or theeffect of the specific product/category of products based on the testresults. For instance, a customer may be concerned about the consumptionof a particular brand of chocolate bar, presenting THE PRIMER SHOP withthe question “how good or bad is for me is the daily consumption of a“BRANDX” chocolate bar?”. Based on the ingredients and nutritionalcontent of this product (outlined at Table 1 below), THE PRIMER SHOP mayrecommend to the customer a testing platform with a selection of geneticbiomarkers evaluating, e.g. diet response, genetic variants related tothe metabolism of sugar, sodium, cholesterol, carbohydrates, saturatedfats and genetic risk for elevated LDL, ability to convert beta-caroteneto vitamin A, predisposition to lactose intolerance etc. Based on theresults, THE PRIMER SHOP will be able to assess the suitability of thisproduct/category of similar products for the consumer, as dictated bythe consumer's genetic code.

One suitable technology for testing a customer's genotype is thatprovided by DNA Electronics, London, UK. This technology utilises arraysof chambers/aliquots, each with particular primers immobilised therein.Different primers target different variations of different genes. IonSensitive Field Effect Transistors (ISFETS) are located within thechambers to sense reactions, e.g. pH changes, resulting from theaddition of bases to the extending primers. Alternatively, other sensingplatforms can be used, such as optical, nanowire and nanopore. Othersuitable technologies based on DNA analysis include, for instance, thoseprovided by Epistem Ltd, QuantumDx Group Ltd, and Cepheid UK Ltd, aswell as non-DNA based platforms, such as those provided by CambridgeNutritional Services Ltd, or Imutest Ltd, which utilise antigen-antibodyinteractions.

THE PRIMER SHOP may have different pre-prepared arrays that cover avariety of applications. For example, a DNA test module 1 may haveprimers both for various aspects of fitness—as illustrated in FIG. 6—andnutrition. Depending on the customer's interest, only the part that isasked for may be accessible to the customer (either by physicallypreventing the running of a test at non-accessible parts, or bypreventing access to the results). This selection is based on thecustomer's expressed interest and/or purchase and is implementedremotely via THE PRIMER SHOP portal.

A “plug-and-play” test module of a DNA test kit can be purchased eitherpreloaded with the primers, or customised according to the customer'sspecific questions/concerns, e.g. with specific primers printed intochambers of the test module. The identity of particular primers andtheir locations loaded onto the module are not disclosed to the customerand are known only to THE PRIMER SHOP. THE PRIMER SHOP maintains adatabase of available/supplied modules mapping module reference ID toprimers and their locations (this data is not associated with customeridentities). After deciding on the set of primers which is relevant tothe lifestyle concern/question or product/category of products ofinterest to the customer, the customer may proceed with the order. Thecustomer pays only for the tests/primers that he/she is interested in.Privacy is secured with regards to a) the selected primers, and b) thegenetic results. THE PRIMER SHOP does not disclose the genetic sequenceof the primers, nor their exact location on the testing platform, to thecustomers or to any third parties. Moreover, the point-of-care nature ofthe kit eliminates the time lag and gives information that the customerwants at the point that he/she wants it.

THE PRIMER SHOP's testing kit, including the plug-and-play DNA testmodule will be delivered to the customer's address. A sample preparationkit can be also sent to the customer in order to perform locally thesample extraction; otherwise, sample extraction could be performedremotely by a third party. The procedure of FIG. 2 is then followed. Thecustomer can run the test by following the instructions, includingloading the biological sample on the testing platform, plugging the testmodule into his home computer (or mobile device, e.g. a smartphone),e.g. using the computer device's USB port. Via an Internet connection,the customer's computer device connects to THE PRIMER SHOP (TPS) portal.THE PRIMER SHOP remotely initiates the test. In the case where the DNAtest module includes a number of sites, with or without primers present,this involves THE PRIMER SHOP activating those sites where primers arepresent and which are required (e.g. paid for) by the customer. As thetest is run, THE PRIMER SHOP remotely monitors progress.

In an exemplary procedure, the module delivers to a server (at THEPRIMER SHOP) data generated by active test sites on the device. Data isaccompanied by a module reference ID read from the module and thelocation(s) (e.g. array address(es)) from which it originates. As onlyTHE PRIMER SHOP knows the primer that is located at a given location fora given module (identified by the reference ID), no confidential geneticinformation is made available at the customer's computer device or toany intermediate location in the Internet. This provides a level ofsecurity that exceeds even that which can be achieved by encryption(although the transferred data may additionally be encrypted).

The test result data is received by THE PRIMER SHOP server and decryptedif necessary (the test module may include a memory storing a public keyof a public/private key pair of THE PRIMER SHOP, allowing the customer'scomputer device to encrypt data it sends to THE PRIMER SHOP). It is thenanalysed, using THE PRIMER SHOP's knowledge of the primers that havebeen used on the test module identified by the module reference ID and adatabase of characteristics that have been mapped to potential results.For example, certain alleles may be mapped to certain characteristics.

Based on the test outcome and analysis, THE PRIMER SHOP generates asummary report of the results. This might be a written report thatsummarizes the results and provides an accompanying discussion includingcertain general advice and recommendations. THE PRIMER SHOP additionallygenerates or applies one or more genetic filter codes based on the testresults. These codes are mapped to certain product and/or serviceproperties. For example, a code “A123” may map to the property “glutenfree”. The codes are encrypted with the private key of THE PRIMER SHOPor with a symmetric key known only to THE PRIMER SHOP.

THE PRIMER SHOP sends the summary report of the results (answering thecustomer's initial question) to the client's device (or using somemessaging service such as email, text etc), together with the generatedor identified encrypted code(s), without disclosing the actual genotypeof the individual. The report and accompanying encrypted code(s) arepreferably encrypted, for example using the public key of thepublic/private key pair provided to the customer on the DNA testmodule—the customer may send its public key to THE PRIMER SHOP togetherwith the test result data (THE PRIMER SHOP does not keep a copy of theuser's private key).

THE PRIMER SHOP may additionally identify to the customer a range ofproducts or services suited to the customer's genotype with an option topurchase. The customer can select from these products and/or servicesdepending on his/her personal preferences, e.g. price, eco-friendlinessof product packaging, brand preference, etc. The Primer Shop maysubsequently keep the customer updated about new tests, products andscientific discoveries. These updates will be sent according to thecustomer's preferred frequency and delivery means.

THE PRIMER SHOP acts as a “genetic filter”—scanning through 100s or1000s of products/services available in the market—in order to recommendto a customer the products/services that are best suited depending onhis/her genetic profile. Therefore, THE PRIMER SHOP customer hasconfidence that he/she is making an optimum purchase, whilst retainingfreedom of choice as he/she will make the final product selection basedon personal, i.e. non-genetic, preferences.

THE PRIMER SHOP provides a platform that allows partner companies toreach individual customers of THE PRIMER SHOP. These partner companiescan have space on the virtual “shelves” of THE PRIMER SHOP, e.g. bymeans of a “click-through” service. Alternatively, partner companies canbenefit from a web browser add-in (plug-in) that helps customers duringpurchases made directly from the partner companies' web portals.

Applications of THE PRIMER SHOP service model extend beyond the examplesprovided for human health and lifestyle, and can be applied to anyliving organism, including animals, plants, microbes, and fungi. Forexample, information may be sought in connection with a pet's lifestyle,nutrition and pedigree history, fertilisers for a specific tree, ormicrobes in the gut. Such tests may be carried out for wellbeing,allergy risk, fitness, nutritional supplements, agricultural production,environmental control/investigation, etc.

Privacy must be a key priority for the service and its customers.Therefore, the service safeguards its customers' confidentiality by notdisclosing primer sequences and genotypes that are being tested.

Example

Consider a customer expressing the lifestyle concern; “do I need vitaminD supplementation?”. THE PRIMER SHOP offers in its catalogue a primerXX, with sequence:

SEQ. ID NO. 1 ATCTCTGTCTCTTAATTATCTCACA[A/C]AGCCAGGTATTTTTTATTGT TAGCT.

This primer maps to the GC gene (Group-Specific Component; Vitamin DBinding Protein)) and can analyse for the SNP Rs2282679. The Rs2282679(A) allele is considered the normal allele and is associated with zerorisk of vitamin D deficiency, while the Rs2282679 (C) is associated withincreased risk of vitamin D deficiency. An individual may a) carry twoRs2282679 (A) alleles and have no increased predisposition to vitamin Ddeficiency, b) carry a Rs2282679 (A) allele and a Rs2282679 (C) allele,having a 1-fold increased risk of having somewhat lower vitamin Dlevels, or c) have two Rs2282679 (C) alleles and have 1.5-fold increasedrisk of vitamin D deficiency. Instead of providing all the aboveinformation to the client, THE PRIMER SHOP approach is as follows.

The customer selects primer XX that can help answering the lifestyleconcern; “do I need vitamin D supplementation?”. However, the actualgene that will be screened and the sequence of the primer are notdisclosed to the customer nor are they sent over the Internet at anystage, not even in encrypted form. This is required as any storage ofgenetic information, outside of THE PRIMER SHOP, represents a securityrisk. [NB. data stored at a customer's computer device is potentially atthe greatest risk due to the prevalence of malware that allows attackersto gain access to private data.] The customer is merely sent a test kitincluding the appropriately prepared DNA test module, with a memory ofthe test module storing the module reference ID. At this stage, THEPRIMER SHOP deletes all information related to the customer's genotypeincluding the summary report (the module reference ID is stored in adatabase, mapped to the primers on the module and their locations, butthis is not associated with any customer identity). THE PRIMER SHOPretains only the customer's basic subscription related data and,optionally, his or her public key in order to allow it to decrypt datasubsequently sent by the customer and encrypted with the customer'sprivate key.

Similarly, the precise details of the test performed using the primer XXare not disclosed at any stage of the service, in order to ensuremaximum privacy. Only the data generated by the primer XX, the testlocation, and the module reference ID are sent online to THE PRIMERSHOP. The analysis returned by THE PRIMER SHOP will not disclose his/heralleles or the genotype, but only the interpretation of the results,e.g. you are/you are not at high risk of developing vitamin D deficiencyand therefore, you do/don't require vitamin D supplementation (i.e. ananswer to the initial question/concern). At this stage, if the customeris at risk of developing vitamin D deficiency, he/she will be presentedwith a range of vitamin D supplements, containing suitableconcentrations of vitamin D (e.g. 0.01 mg daily), to choose from, suchas Mum's Ddrops® in liquid form, Boots™ Vitamin D tablets, Solgar™Vitamin D3 400IU softgels or tablets, SimplySupplements™ Vitamin D 400IUetc. Furthermore, this interpreted information is sent from THE PRIMERSHOP to the customer in encrypted form to ensure that even this data iskept as secure as possible.

As noted above, the summary report provided to the customer may includeproduct or service suggestions. Where the report is displayed in a webbrowser of the customer's computer device, the customer may be able toselect a product or service by clicking on a link, whereupon an ordermay be made through THE PRIMER SHOP's purchasing portal or via apartner's portal (i.e. a click-through process). Order information maybe secured using the customer's public/private key pair.

The client's computer device does not retain the test results. Rather,it retains only the summary report and the genetic filter code(s)(whilst the genetic filter codes have been decrypted to a first levelusing the customer's private key, they remain encrypted with THE PRIMERSHOP's private key). By sending the (encrypted) code(s) to THE PRIMERSHOP, where they are decrypted using THE PRIMER SHOP's private key, THEPRIMER SHOP is able to repeat the analysis using, for example, any newlyacquired data (e.g. genetic/scientific or newly available products andservices) and provide an updated product and/or service selection to thecustomer. Once again, after the updated report has been prepared andsent to the customer, THE PRIMER SHOP deletes all genetically relateddata including the report and the genetic filter code(s).

An alternative approach to facilitating product or service purchasinginvolves THE PRIMER SHOP providing to the customer's computer device anInternet browser add-in or plug-in (or a similar component for adedicated interface that a product provider may have, e.g. an app forAMAZON™). This is illustrated schematically in FIG. 3, and the operatingprocedure in FIG. 4. The plug-in has access to the previously receivedgenetic filter code(s) stored at the customer's computer device. Onceinstalled into the Internet browser, the customer opens his or her webbrowser to begin shopping online—step 100—and clicks on the TPS buttonfor add-in assistance—step 200. The plug-in accesses the customer'sencrypted genetic filter code(s), and sends this to THE PRIMER SHOPtogether with identity of the accessed website—Steps 300/400. NB. Thisinformation is sent anonymously preventing THE PRIMER SHOP fromassociating the genetic filter codes with the customer. THE PRIMER SHOPdecodes the genetic filter codes with its private key and returns to thecustomer's plug-in, information that it can use to filter theinformation presented to the user in the browser window, for example afiltered list of products—Step 500. [This information can again be sentencrypted with the customer's public key (e.g. sent with the customerrequest).] For example, the plug-in may “grey-out” certain products orservices that are deemed unsuitable for the customer, and the customercan proceed to choose a product from the filtered selection—Step 600. Inthis way THE PRIMER SHOP acts as a “gateway” to the partner company'swebsite.

Prior to applying the filter, the plug-in may initiate a customerauthentication procedure, requiring the customer to authenticate him orherself to THE PRIMER SHOP server. THE PRIMER SHOP can then trackpurchases made when the filter is applied, e.g. to reconcile chargesmade by THE PRIMER SHOP to the partner company. This authentication andtracking procedure is not associated with the procedure described in thepreceding paragraph—i.e. the sending of the genetic filter codes to THEPRIMER SHOP. It will be appreciated that the use of this approach leaksno genetically related information outside of the customer's computerdevice. Specifically, no data is leaked to the partner company fromwhich purchases are made.

THE PRIMER SHOP may provide its customers with an application (“app”)that can be run on smartphones and other mobile devices. This tool canbe used as a product selection or lifestyle assistant for “on-the-spot”in-store or online purchases. The app will allow the user to scanproduct barcodes in-store, retrieve information associated with thegenetic filter code(s) retrieved from THE PRIMER SHOP, and filterproducts by narrowing down selection based on the user's genetic filtercode(s). Again however, the app only has access to the encrypted geneticfilter code(s) and no genetically related information is leaked. FIG. 5illustrates the operation of an exemplary app.

Where product manufactures/providers have a partner relationship withThe Primer Shop, the products may carry a “THE PRIMER SHOP QuickResponse code” (TPS-QR code). The QR code contains, in encrypted form, alist of the genetic filter codes relevant to the specific product towhich it is attached. [The TPS-QR code is encrypted in accordance withthe policy of THE PRIMER SHOP of not disclosing the actual primers'sequences and the actual genotype of its clients.] This allows asuitable app, installed on the customer's computer device to send aquery to THE PRIMER SHOP including the QR code data and the encryptedcustomers genetic filter codes. Again, THE PRIMER SHOP is able to returndata that allows the app to provide product filter data, e.g. adviceconcerning the suitability of the product and/or suitable alternatives.

The app is an intelligent, interactive and intuitive assistant. Forexample, when the customer is in the premises of a grocery store, it mayremind the customer of the type of products he/she needs to buy. Whenthe customer is in the gym, it may remind him or her what sort ofexercises are necessary (possibly being linked with some mechanism—e.g.accelerometers, motion sensors, etc.—provided within the device to trackactual exercises performed).

THE PRIMER SHOP may provide customers with a two-part test module have afirst part configured to be connected to the customer's computer device,e.g. via a USB connection. This first part is further configured toreceive, via a plurality of sockets, a plurality of disposable sampleparts. The sample parts include the chosen primers, and means forreceiving the genetic material to be analysed. Sample parts areactivated individually, e.g. after insertion into the first part. Thisapproach allows tests to be carried out in parallel, but with eachstarting at a different time. This is illustrated in FIG. 7 which showsthe sample preparation kit 100, together with the first part 200 havingan Input/Output interface for connection to the customer's computerdevice. The first part 200 has sockets for connecting six disposablesample parts 300.

FIG. 8 illustrates schematically two approaches to providingpersonalised genetic-related advice to customers. This can take as astarting point genetic information and, based on this provide advicerelating to specific products (or services etc), or can take as astarting point a product (or service etc.), such as a brand of chocolatebar, and then recommend a genetic test.

FIG. 9 illustrates schematically a product ordering service utilisingthe method and apparatus described above. This presents the followingsteps:

Step 100: The user purchases a test-kit plug-and-play platform, appliesbiological sample and connects via a computer or mobile device to theInternet

Step 200: Customer's genetic filter code sent to THEPRIMERSHOP portal

Step 300: Genetic predisposition determined

Step 400: Product mapped according to the customer's genetic filter code

Step 500: Product recommendations retrieved by THEPRIMERSHOP portal andmatched back to the customer's genetic filter code

Step 600: Product recommendations sent back to the customer

Step 700: Customer chooses the product of his/her choice and proceeds tothe purchase

Steps 100 to 700 are being performed via secure server link by usingprivate and public key system encryptions.

Here we are proposing a novel method/apparatus to apply breath analysisinto lifestyle management, in particular selection of suitablenutritional products. For example, we may look at 13C-octanoate releaserate which is correlated with the absorption of medium-chain fattyacids. Accordingly, the person may be advised to temporarily selectlower-fat products.

Another example is Lactose intolerance and maldigestion. While thegenotypes can give an indication of possibility of lactose intolerance,breath analysis on H₂ and CH₄ can further clarify whether the symptomsare around lactose intolerance or maldigestion.

Similarly, breath analysis can indicate of the activity of themicrobiome inside the stomach. When digesting food, it is not just ourbody organs that are involved; there are hundreds of thousands ofbacteria that are involved too. Therefore, knowing about the conditionof the microbiome can help understanding how the nutrition intake can beadjusted accordingly.

FIG. 30 gives an overview of a system/method that helps the user todecide (on product selection or activity) by giving recommendations.Based on the level of individual or pattern of a group of biomarkers(the compounds in breath), it can identify/predict the possible outcomesof each decision. Therefore, recommending which may have a potentiallybetter outcome than the others. In this system, historical analysis mayalso be taken into account to show how the metabolism behaviour haschanged.

The biological and physiological and activity measurements may consistof a variety of information and parameters. For example, it may takeinto account the person's genetic background, epigenetic analysis,genetic expression, hormones and vitamins levels, physical activity andexercises, body weight and height, glucose levels, etc. It may alsoinclude the historical breath test results.

For example, a person might be a carrier of a Single NucleotidePolymorphism (SNP) which may eventually result in the person becoming adiabetic. Monitoring the acetone level change in the breath, canindicate if the person is at risk and needs to take more control ofhis/her diet, or perhaps otherwise indicate that he/she is doing alrightand the genetic variation has remained silent.

Reference has been made above to the use of a smartphone with barcodescanning functionality to identify products and provide productrecommendations based on a user's personal genetic information. It isproposed here to implement a similar functionality in other “wearable”device types. Of particular interest is the implementation within awristband-type device. FIG. 10 illustrates schematically one such devicewhere the functionality is implemented within a module coupled between,or formed integrally with, a pair of wrist straps. It will beappreciated of course that the module may be configured to attach, e.g.snap-fit, to an existing wristband of a watch, bracelet, fitness trackerband, etc. As will be described below, the module (or “wristband” as itwill be referred to hereinafter) is configured to communicate wirelesslywith a computer device such as a smartphone, with the smartphone in turncommunicating, e.g. via a wireless data network, with (cloud) serversoperating a backend date service.

In very general terms, the wristband is constructed and configured tomaintain data relating to current products including product codes andrespective product recommendations determined using personalised geneticdata, preferably, though not necessarily, of the wearer. These productcodes correspond to machine readable codes such as 1D or 2D barcodes(e.g. UPC/EAN), QR, ISBN, PDF417, Data Matrix etc, etc. The wristband isprovided with a product code reader such as a barcode reader for readingproduct codes printed or otherwise provided on products intended forpurchase or use. One such example of a product code reader is a camera,with associated processing circuitry for recognising an imaged barcodeand for converting the barcode into a digital code. This wristbandfurther comprises processor circuitry for using the read product code asa look-up key in the database of product codes and productrecommendations in order to retrieve the product recommendation. Thewristband is also provided with a means for providing an indication ofthe determined product recommendation to the wearer. This could includea vibration motor which provides a vibration signal. Of course, themeans may alternatively or additionally provide a visual or audiblesignal to the user.

In a typical use scenario the wristband may be loaded, via thesmartphone, with product codes for grocery items available within his orher geographic region, e.g. the United Kingdom. The wristband is alsoloaded with respective product recommendations for the wearer (or atleast as many as are available and/or useful). These recommendations mayhave been determined by the smartphone by applying the TPS codes for thewearer with product data downloaded from the cloud. For example, thesmartphone may download the product codes from the cloud together withdetails of product content. For a particular product having say a highfat content, application of the TPS codes may indicate that the productis not recommended for the wearer and as such the product, or ratherproduct code, is associated with a relatively low productrecommendation. The recommendation could be a simple yes or no or may bea value, e.g. between 1 and 10. The wearer may further personalise theservice by manually inserting lifestyle preferences (e.g. sugar orcalorie intake reduction goals etc), e.g. using a management interfaceof the smartphone.

When the wearer enters a grocery store, the wristband will already havebeen loaded with product codes and product recommendations so noconnectivity, e.g. to the cloud or to the smartphone, is required. Thewearer identifies a product of interest and scans the product barcode.He or she is given immediate feedback, e.g. by a short vibration, thatthe product is recommended. If the product is not recommended, aprolonged vibration may be generated. Based on this feedback the clientis lead, or “nudged”, towards a healthier and/or more appropriatechoice. If the display on the wristband is suitable, the wristband mayprovide an indication of a more suitable product if one is availablewithin the database. The wristband may also communicate with thewearer's smartphone at this point, if a connection is available, toprovide such an indication and/or to provide additional productinformation.

The wristband may be further configured to receive confirmation that ascanned product has been purchased, and to log this data for future use.An indication may be given by the wearer pressing a button on the wristband, tapping on the module, shaking his or her wrist, etc. A mechanismmay also be provided to allow removal of a product from a purchase list,e.g. due to a change of mind. Alternatively, purchase data may beprovided to the smartphone by scanning a store till receipt, or by someinteraction with the cloud whereby the store transfers purchase detailsto an account which can be accessed by the user's smartphone.

Data identifying purchase may be fed back to the mechanism thatdetermines the product recommendations for the wearer. For example, inthe case that the wearer's genetic information results in a generallyhigh or positive recommendation for a given product, if the wearer isdetermined to be consuming a large amount of that product or of certainof its contents, e.g. fat, the product recommendation may be reduced tonudge the wearer to reduce consumption.

Although genetic information is of course personal, it is recognisedthat many product purchases, especially concerning groceries, areintended for consumption by a group of people, e.g. by family and/orfriends. It may therefore be desirable to allow the database in awristband to be updated to reflect the product recommendations for agroup of individuals. This may be achieved by merging the data, e.g. byaveraging the product recommendations across the members of a group,and/or by taking into account certain product or ingredient intolerancesor allergies. This is considered in more detail below.

A more sophisticated service may be able to take account of datarecorded in a product barcode including, for example, productingredients, nutritional content, % RDA (Recommended Daily Allowance) or% RI (reference intake) or % NRV (nutrient reference value), allergeninformation, product features, functions, the origin of productingredients, manufacturing procedures, product mileage, organiccertifications etc. This data can be used to adjust the productrecommendations.

FIG. 10 gives an overview of the system application. The wearer scansthe product barcode and wristband outputs a recommendation about theproduct. This can be implemented in different ways. The analysis forgiving a recommendation can be done locally (FIG. 11) or it can bepre-loaded to the device (FIG. 12) as discussed above. In bothscenarios, the list can be updated, for example through a cloud-basedserver (FIG. 13), directly or via the wearer's smartphone.

FIG. 14 shows an example schematic block diagram of the wristbandstructure. The components include:

A barcode scanner such (e.g. a CMOS imager) that scans the productbarcode.

A random access memory that stores the read barcode

The Barcode Memory (database) that contains a list of all productbarcodes with their related personalized results, i.e. productrecommendations.

(A memory storing the genetic information (the genotyping test result,e.g. TPS codes) of the user in case of local processing.)

As has been considered above, the system helps the user in identifyingthe products that are not suitable and are better to be avoided. Byfurther refinement, for example taking into account bio/physiologicalconditions of the user, the system can encourage the user towardsproducts that are potentially more suitable for the user. FIGS. 15 and16 illustrate this concept. The Figures illustrate a system which ratesproducts on a scale of “1” to “7”, where “1” is highly recommended and“7” of not recommended.

As has already been alluded to, personal genetic information may besupplemented with additional information, such as user preferences, inorder to determine product recommendations. Some of this information maybe taken into account when determining the TPS codes or may be usedtogether with the TPS codes to determine product recommendations. FIG.17 illustrates schematically a “holistic” approach to the determinationof product recommendations, where the results output (on the right ofthe diagram) are the product recommendations. Of particular significancehere are epigenetic information and sensed data.

Epigenetic Data

It is known that epigenetic data for user can identify changes in theuser's physiology due, for example, to changes in the user's lifestyleand diet. By performing epigenetic tests on the user at certain timeintervals, product recommendations may be changed/refined. For example,epigenetic data may indicate, in combination with data collectedrelating to product purchases, that the purchase or non-purchase ofcertain products has resulted in a positive health benefit for the user.The system may take this into account when updating the productrecommendations, e.g. where the user was previously not recommended toconsume a high fat product, the recommendation for this product might benudged up to indicate to the user that some limited consumption is nowless harmful.

Epigenetic data may be obtained, for example, by analyzing a sample of auser's genetic material (obtained using a cheek swab, saliva sample,blood sample etc) or transcription data by analyzing a user's mRNA.

Sensed Data

The proposal here to incorporate the system into a wearable device suchas a wristband makes possible the use of sensed data such as biochemicaland physiological/environmental data. In particular, the device may beconfigured to monitor the wearer's heart rate and hence determine therate at which the wearer burns calories. This sensed data can be used tomodify the product recommendations in any of the short, medium or longterm. For example, if the system detects that the wearer has just beenextremely physically active, a drink with a high sugar content may berecommended. Thereafter the recommendation for that drink returns to thelong term value.

FIG. 18 illustrates schematically a device architecture that enables asophisticated calculation and recalculation of product recommendations.The system includes biosensors for measuring biochemical andbio-physiological data of the wearer, and circuitry for combining thiswith the genetic data directly or indirectly. Of course, certain of thecircuitry may be implemented in the smartphone and/or cloud.

FIG. 19 shows a still more sophisticated system which takes account ofgenotypic, epigenomic, biological, physical, and behaviouralcharacteristics of the user. An example of a biochemical sensor may be asensor, placed on the underside of the wristband, that uses microneedlesto measure the wearer's glucose, cholesterol, or hormone levels. Thedevice may additionally be provided with environmental sensors, e.g. aUV sensor. The results generated by such sensors may also be fed intothe determination and/or use of the product recommendations.

Given the current popularity of fitness bands for monitoring activity,health, etc, it would be of great interest to incorporate the systemdescribed here into such a fitness band. Of course, fitness bandsalready include some of the sensors proposed above. There may be somesynergy between the components of the fitness bands and the newfunctionality. For example, optical components of a pulsed-light heartrate monitor may be incorporated into a barcode scanner to avoid theneed for an additional light source and/or light detector.

The device may be enhanced to include a sighting or targeting means toaid in locating and capturing a barcode to be scanned. For example, thedevice may project a light spot onto a central point of the scanningarea. The user locates the light spot onto the centre of the barcode.The device may have a means for automatically recognising a barcode andcapturing the code, or it may require the user to press a button, orpossibly provide a voice command.

By means of a management application, e.g. in the wearer's smartphone,the wearer may input data relating to personal allergies, e.g. a nutallergy, or an intolerance. These may be factors that are not picked upby a genetic test and which are therefore not reflected in the TPAcodes.

It is desirable to maximise battery life in the device, and this can bechallenging given possible high power demands of scanning. The devicemay therefore be configured to operate in a low power sleep mode and arelatively high power active mode, the device being operable in thesleep mode to recognise a generic product code and cause a switch to theactive mode. Thus, for example, the imaging system of the device may beable to recognise a barcode without necessarily reading the code, e.g.it is merely able to identify a set of black and white lines. Only whensuch a pattern is detected does the device switch to a high power modein which the barcode is read, decoded, and a recommendation determinedand presented.

Returning now to the proposal that product recommendations may beevaluated across a group of individuals, as has already been noted,shopping is not necessarily always personal, but may be carried out fora family/household. The shopping basket is dominated by products thatall the people in a house use. In this case, the system can determine anoptimum product list, or tell the user whether a particular product issuitable for all in the house or if it is in particular avoided by amember. FIGS. 20 and 21 show how the system can help sharing productlists and creating an optimum common list of products among peoplesharing a common basket. By way of example, as shown in FIG. 20, theproduct recommendation lists for two individuals may be merged toproduce a single list that is downloaded onto the device of the personthat is doing the shopping. Alternatively, as shown in FIG. 21,individual lists may be loaded onto the shopper's device and the listsexamined and the results combined to determine a product recommendation.

FIG. 22 illustrates an example of how a calculation can help identifyingthe optimum product choice from a number of biscuit brands for a groupof four individuals. Each biscuit for each person have been given aproduct recommendation (score). The lower (negative) the score is, theless suitable it can be considered. The higher the score is, the betterthe biscuit matches the user's template. Now, in order to find theoptimum biscuit, the overall score is calculated. The biscuit that givesthe highest score is the product of choice. However, the biscuit chosenshould be the one that does not have a negative score for any of thefour individuals. In this example, Biscuit 2 is recommended.

This concept of sharing can be implemented in different ways.Considering the wearable device (for example a wristband), a wirelesslink between two or more devices can allow the product list and profiletransfer (sharing). This link may be, for example, NFC, infrared,Bluetooth, Wi-Fi, etc, and be activated when the peer wristbands getclose to each other or touch each other, i.e. “bump” together. Someprior approval may be required to avoid accidental sharing, e.g. a givenuser may add other users to his or her contact list using the smartphonemanagement application. A possible implementation is illustratedschematically in FIG. 23. Of course, to take account of the fact that auser may be shopping for different groups, different combinations ofindividuals within a group, of for him or herself alone, the system maybe configurable. For example, the wearable device may allow the wearerto select a combine option and, if so, to select the individuals towhich the combination relates.

Because the device is making use of personalised data it may in somecircumstances be desirable to be able to identify the wearer. Considerfor example the case where a family share a single device. In order toallow the device to select the correct product recommendations for thatindividual, the device may be configured to identify the individualbased on sensed data such as physiological date, motion data (e.g. aparticular pattern of movement).

In some cases a user may not have access to product recommendations foranother individual for whom he or she is shopping, either because thatinformation has not been shared or because the other individual has notobtained the data (e.g. has not subscribed to the service). If the otherindividual is a genetically related family member, it may be useful toprovide a filtering of the product recommendations based upon genes thatare known to be hereditary. Product codes received from the smartphonefor the wearer may be marked to identify those that are associated withsome hereditary traits. Recommendations may only be provided for thoseproducts provided with the marker. As with the sharing option, thedevice may be provided with some means to switch this hereditary-basedselection on and off

The system can be implemented as a wearable, carrying the users'personalised product lists with barcodes. When the user scans a productbarcode, the system can tell the suitability of the user's choice. Theuser may be notified of the outcome in different ways. For example, acolour light can be projected on the product barcode (e.g. green showingsuitable, red warning of its unsuitability, and amber to let thecustomer know that while suitable, there are actually better ones forhim/her); the screen colour might change, or it might vibrate.

FIG. 24 illustrates four alternative embodiments of a wearable deviceimplementing the key functionality described above. These embodimentsare: A. a ring or keyring; B. a standalone unit suitable for example forcarrying in a purse, bag or pocket; C. a module for attachment to awristband of a watch; D. a module integrated into a wristband.

FIG. 25 illustrates schematically a device with an audio interfaceincluding a microphone (“Mic”) that allows the wearer to use voicecommands to control the device. This would enable the wearer to interactwith the device to, for example, confirm that a scanned product is beingpurchased. Other ways for the wearer to interact with the device caninclude:

Tapping on the screen (for example, a single tap to choose the scannedproduct, a double-tap to refuse to take the product;

Swapping fingers over a screen; and

Blocking the scanner camera, e.g. by raising fingers/hand.

Assuming that the device includes some motion detection mechanism, e.g.accelerometers, the device may track the hand movement for identifying apurchasing decision; i.e. whether it is toward a basket or toward theshelves. The device may alternatively configured to recognize particularhand gestures, e.g. the shake of a hand etc and associate these with apurchasing decision.

The device may use body movements to identify when the user isinterested to a scan. For example, when the hand in a certain position,it might automatically turn on the scanning system. The device mayalternatively use a location service module, for example a GPS, to turnon automatically when the user enters a store. Location informationdetermined in this way may also be helpful in switching on or offcertain parts of the product list. For example, when a wearer enters aparticular store, the product list may be filtered to use only productsavailable in that store. This will prevent unavailable products beingoffered to the user (if such an option is enabled).

System users may have a service account where he/she can use a varietyof system features (overview in FIG. 26). For example, scanned productpurchases can be loaded into the user's account. The user can thenapprove if he/she has consumed all/some of the products via somegraphical user interface, e.g. on the user's smartphone (FIG. 27). Thedefault/expected amounts can be predicted based on the user's previousvalues. The user just needs to adjust and/or approve the estimates. Theuser can have the option to manually enter data (FIG. 28), e.g. usingthe management application. The application guides the user towardoptimum changes, providing an analysis of his or her “performance” (FIG.29).

It will be appreciated by the person of skill in the art that variousmodifications may be made to the above described embodiments withoutdeparting from the scope of the present invention. For example, whilstan exemplary use of the system and device involves human use, theinvention can be applied to animals including pets and horses, plants,fungi, etc. Also, whilst the products may be food and beverages, theinvention applies also to other grocery products including detergentsand other cleaning products, as well as other products whose suitabilitydepends upon genetic traits, e.g. footwear, glasses, etc.

TABLE 1 BrandX bar Nutritional facts Serving size 52.7 g Calories 250Calories from fat 110 Amount per Serving % DV* Total fat 12 g 18% Saturated fat 4.5 g 23%  Trans Fat 0 g Cholesterol 5 mg 2% Sodium 120 mg5% Total carbohydrates 33 g 11%  Dietary fiber 1 g 4% Sugars 27 gProtein 4 g Vitamin A 0% Vitamin C 0% Calcium 4% Iron 2% *Percent dailyvalues (DV) based on a 2000 calorie diet Ingredients Milk chocolate(sugar, cocoa butter, chocolate, skim milk, lactose, milkfat, soylecithin, artificial flavor) Peanuts Corn syrup Sgar Palm oil Skim milkLactose Partially hydrogenated soybean oil Salt Egg whites Artificalflavour

REFERENCES

-   “The Breath Test That Diagnoses Diabetes” Wall Street Daily,    published Thu, Jan. 29, 2015, Martin Denholm, Managing Editor    http://www.wallstreetdaily.com/2015/01/29/diabetes-acetone-breath-test/-   Michaletz, P. A., Cap, L., Alpert, E. and Lauterburg, B. H. (1989),    Assessment of mitochondrial function in vivo with a breath test    utilizing α-ketoisocaproic acid. Hepatology, 10: 829-832.    doi:10.1002/hep.1840100513-   Misselwitz, B., Pohl, D., Fruhauf, H., Fried, M., Vavricka, S. R., &    Fox, M. (2013). Lactose malabsorption and intolerance: pathogenesis,    diagnosis and treatment. United European gastroenterology journal,    1(3), 151-159.-   Jackson, S. J., Leahy, F. E., McGowan, A. A., Bluck, L. J. C.,    Coward, W. A., & Jebb, S. A. (2004). Delayed gastric emptying in the    obese: an assessment using the non-invasive 13C-octanoic acid breath    test. Diabetes, Obesity and Metabolism, 6(4), 264-270.-   Berg, L. K., Fagerli, E., Martinussen, M., Myhre, A. O., Florholmen,    J., & Goll, R. (2013). Effect of fructose-reduced diet in patients    with irritable bowel syndrome, and its correlation to a standard    fructose breath test. Scandinavian journal of gastroenterology,    48(8), 936-943.-   Martins, I. J., Tran, J. M. L., & Redgrave, T. G. (2002). Food    restriction normalizes chylomicron remnant metabolism in murine    models of obesity as assessed by a novel stable isotope breath test.    The Journal of nutrition, 132(2), 176-181.-   The volatile metabolome and microbiome in pulmonary and    gastro-intestinal disease Marc van der Schee, PhD thesis, University    of Amsterdam (2015)-   The application of FAIMS gas analysis in medical diagnostics, J. A.    Covington, M. P. van der Schee, A. S. L. Edge, B. Boyle, R. S.    Savage, R. P. Arasaradnam, Analyst, 2015-   A simple breath test for tuberculosis using ion mobility: A pilot    study, A. S. Sahota, R. Gowda, R. P. Arasaradnam, E. Daulton, R. S.    Savage, J. R. Skinner, E. Adams, S. A. Ward, J. A. Covington,    Tuberculosis, 2016-   Detection of Colorectal Cancer (CRC) by Urinary Volatile Organic    Compound Analysis, Ramesh P. Arasaradnam, Michael J. McFarlane,    Courtenay Ryan-Fisher, Erik Westenbrink, Paula Hodges, Matthew G.    Thomas, Samantha Chambers, Nicola O'Connell, Catherine Bailey,    Christopher Harmston, Chuka U. Nwokolo, Karna D. Bardhan, James A.    Covington, Plos One, 2014. Issue 9|e108750-   Towards the non-invasive detection of colorectal cancer: The role of    electronic noses (E-nose) and Field Asymmetric Ion Mobility    Spectroscopy (FAIMS), Westenbrink E, Arasaradnam R P, O'Connell N,    Bayley C, Nwokolo C, Harmston C, Bardhan K D, Covington J.-   A novel tool for non invasive diagnosis and tracking of patients    with Inflammatory Bowel Disease (IBD), Arasaradnam R P (MD, PhD),    Ouaret N (MSc), Thomas M G (MSc), Quraishi N (MD), Heatherington E    (RN), Nwokolo C U (MD, DM), Bardhan K D (MD, PhD), Covington J A    (MSc, PhD).-   Application of a Novel Tool for Diagnosing Bile Acid Diarrhoea,    James A. Covington, Eric W. Westenbrink, Nathalie Ouaret, Ruth    Harbord, Catherine Bailey, Nicola O'Connell, James Cullis, Nigel    Williams, Chuka U. Nwokolo, Karna D. Bardhan, Ramesh P. Arasaradnam,    Sensors, 2013. 13(9), 11899-11912-   Differentiating Coeliac Disease from Irritable Bowel Syndrome by    Urinary Volatile Organic Compound Analysis—A Pilot Study, Ramesh P.    Arasaradnam, Eric Westenbrink, Michael J. McFarlane, Ruth Harbord,    Samantha Chambers, Nicola O'Connell, Catherine Bailey, Chuka U.    Nwokolo, Karna D. Bardhan, Richard Savage, James A. Covington, Plos    One, 2014. Issue 10|e107312-   Review article: next generation diagnostic modalities in    gastroenterology—gas phase volatile compound biomarker    detection, R. P. Arasaradnam, J. A. Covington, C. Harmston, C. U.    Nwokolo, Wiley Online Library, 2014. Issue 8-   The Detection of Patients at Risk of Gastrointestinal Toxicity    during Pelvic Radiotherapy by Electronic Nose and FAIMS: A Pilot    Study, James A. Covington, Linda Wedlake, Jervoise Andreyev,    Nathalie Ouaret, Matthew G. Thomas, Chuka U. Nwokolo, Karna D.    Bardhan, Ramesh P. Arasaradnam, Sensors, 2012. 12, 13002-13018-   Towards the detection of bile acid diarrhoea: A novel non-invasive    approach using electronic noses (E-nose) and Field Asymmetric Ion    Mobility Spectroscopy (FAIMS), Westenbrink E, Arasaradnam R P,    Thomas M, O'Connell N, Bayley C, Nwokolo C, Bardhan K D, Covington    J.-   LESA FAIMS mass spectrometry for the spatial profiling of proteins    from tissue, Rian L. Griffiths, Andrew J. Creese, Alan Mark Race,    Josephine Bunch, and Helen Jill Cooper, Anal. Chem., Just Accepted    Manuscript, 2016-   Determination of a Urinary Drug Metabolite using Liquid    Chromatography Combined with FAIMS-MS and FAIMS-In Source CID-MS,    Robert W. Smith, Danielle E. Toutoungi, James C. Reynolds, Ashley    Sage, Anthony W. T. Bristow, Andrew Ray, Daniel J. Weston, Ian    Wilson, Billy Boyle, Cohn S. Creaser.-   Enhanced performance in the determination of ibuprofen 1-β-O-acyl    glucuronide in urine by combining high field asymmetric waveform ion    mobility spectrometry with liquid chromatography-time-of-flight mass    spectrometry, Robert W. Smith, Danielle E. Toutoungi, James C.    Reynolds, Anthony W. T. Bristow, Andrew Ray, Ashley Sage, Ian D.    Wilson, Daniel J. Weston, Billy Boyle, Colin S. Creaser.-   Rapid, Accurate and on-site detection of C. difficile in Stool    Samples, Marije K. Bomers, Frederik P. Menke, Richard S. Savage,    Christina M. J. E. Vandenbroucke-Grauls, Michiel A. van Agtmael,    James A. Covington, Yvo M. Smulders. Am J Gastroenterol 2015;    110:588-594; doi: 10.1038/ajg.2015.90-   Liquid extraction surface analysis field asymmetric waveform ion    mobility spectrometry mass spectrometry for the analysis of dried    blood spots Joscelyn Sarsby, Rian L. Griffiths, Alan Mark Race,    Josephine Bunch, Elizabeth C. Randall, Andrew J. Creese, and Helen    Jill Cooper, Analytical Chemistry 2015-   Supervised Machine Learning and Field Asymmetric Ion Mobility    Spectrometry Brian Azizi & Georgios Pilikos, University of Cambridge-   Non-invasive exhaled volatile organic biomarker analysis to detect    inflammatory bowel disease (IBD), Ramesh P. Arasaradnam, Michael    McFarlane, Emma Daulton, Jim Skinner, Nicola O'Connell, Subiatu    Wurie, Samantha Chambers, Chuka Nwokolo, Karna Bardhan, Richard    Savage, James Covington. Digestive and Liver Disease, 2015.-   Liquid Extraction Surface Analysis Mass Spectrometry Coupled with    Field Asymmetric Waveform Ion Mobility Spectrometry for Analysis of    Intact Proteins from Biological Substrates, Joscelyn Sarsby, Rian L.    Griffiths, Alan M. Race, Josephine Bunch, Elizabeth C. Randall,    Andrew J. Creese, and Helen J. Cooper. Analytical Chemistry 2015.-   Breathomics—exhaled volatile organic compound analysis to detect    hepatic encephalopathy: a pilot study, R P Arasaradnam, M McFarlane,    K Ling, S Wurie, N O'Connell, C U Nwokolo, K D Bardhan, J Skinner, R    S Savage and J A Covington. Journal of Breath Research, 2016.-   Variation in Gas and Volatile Compound Emissions from Human Urine as    It Ages, Measured by an Electronic Nose, S. Esfahani, N. M.    Sagar, I. Kyrou, E. Mozdiak, N. O'Connell, C. Nwokolo, K. D.    Bardhan, R. P. Arasaradnam and J. A. Covington, Biosensors, 6(1), 4,    2016

1. A wearable device comprising: a memory storing a database of productcodes and associated product recommendations derived from personalisedbiological information; a product code reader for reading a product codeor data from a product; a processor for using a read product code orread data to perform a look-up in the database to obtain a productrecommendation for the associated product; and an indicator forproviding an indication of the obtained product recommendation to awearer of the device.
 2. A wearable device according to claim 1, thedevice comprising a wristband or wriststrap.
 3. A wearable deviceaccording to claim 1, wherein said product reader comprises a camera. 4.A wearable device according to claim 3, wherein said product code readercomprises a processor for detecting a barcode or other machine readablecode within image data captured by the camera.
 5. A wearable deviceaccording to claim 1 and comprising an interface for facilitating datacommunication with a smartphone.
 6. A wearable device according to claim5 and comprising a processor for receiving database updates from asmartphone via said interface and for using these updates to update saiddatabase.
 7. A wearable device according to claim 1, the wearable devicebeing a smartphone.
 8. A wearable device according to claim 1 andcomprising one or more physiological and/or biometric sensors and/orbiosensors for monitoring a wearer's genetic information, and aprocessor for dynamically updating product recommendations in thedatabase using sensed data.
 9. A wearable device according to claim 1,wherein said indicator comprises a light projector for projecting saidindication onto a product whose product code is being read.
 10. Awearable device according to claim 1, wherein said product is animbibeable product.
 11. A wearable device according to claim 1 andcomprising one or more motion sensors and a processor configured toreceive data from the motion sensor(s) and determine a motion of thewearable device indicative of an intention to purchase the product. 12.A wearable device according to claim 1, wherein said personalisedbiological information relates to two or more individuals.
 13. A systemcomprising a wearable device according to claim 1 and a portablecomputer device, the portable computer device comprising a processor andmemory for obtaining and storing personalised biological information ofa user, for using said personalised biological information to deriveproduct recommendations for respective products and for associating theproduct recommendations with product codes for the products, and fortransmitting the product recommendations and associated product codes tothe wearable device.
 14. A method of providing product advice to a user,the method comprising: reading data on a product label using a wearablecomputer device; interpreting the data using biological data stored onthe device, the biological data relating to the user and having beenpreviously obtained by means of an analysis of a biological sampleobtained from the user; and based on the interpretation, presenting on adisplay of the device, or indicating via some other visual, audio, ortactile interface of the device, advice relating to the product, theadvice being tailored to the user.
 15. A method according to claim 14,wherein said wearable computer device comprises a wristband orwriststrap and is worn on the wrist of the user.